Senior Medical Writer — Regulatory Submissions (Oncology)
Syneos Health/ inVentiv Health Commercial LLC
Syneos Health/ inVentiv Health Commercial LLC is looking for a Sr. Principal Medical Writer to develop high-quality clinical documents for global submissions. The role requires extensive knowledge of regulatory standards and substantial experience in the biopharmaceutical industry. As a lead writer, you will guide project teams, ensure compliance with guidelines, and mentor less experienced writers. The company promotes a culture of growth and offers a competitive benefits package, including health benefits and flexible paid time off. #J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC
$95k - $210.9k
Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every...SeniorRegulatoryContract workFlexible hours- ...supports the pharmaceutical, biotech, and medical device industries with a proven,... ...scientific approach to complex trial data and regulatory submission challenges. With a global footprint... ...minimal supervision, the Medical Writer will critically evaluate, analyze, and...SeniorRegulatoryRemote workWorldwide
$70.1k - $145k
...Job Responsibilities Senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents... ...safety update reports, development plans, IND/IND submissions, integrated summary reports, NDA and eCTD...SeniorRegulatoryFlexible hours- MMS Holdings Inc is seeking an experienced Medical Writer based in Denver, Colorado. The role involves writing and editing clinical documents... ..., and mentoring team members. A strong background in regulatory writing and at least 3 years of experience in the pharmaceutical...SeniorRegulatoryRemote job
$150k - $195k
Travere Therapeutics is seeking an Associate Director, Medical Writing to oversee regulatory submissions and ensure compliance with medical writing standards. You will lead medical writing projects and collaborate with cross-functional teams to deliver high-quality documents...SeniorRegulatoryRemote work$94.9k - $135.6k
Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy for pre-approval and post-approval activities. The role demands... ...tasks. Responsibilities include authoring high-quality submissions and mentoring junior staff. This position offers a remote working...SeniorRegulatoryRemote job$70.1k - $145k
Syneos Health/ inVentiv Health Commercial LLC is seeking a Senior Medical Writer in Colorado who will lead medical writing deliverables for clinical and regulatory projects. This position involves delivering high-quality documents, managing client expectations, and ensuring...SeniorRegulatory- Responsibilities Provide regulatory leadership and oversight for ongoing... ...filings (IND/CTA/BLA/MAA submissions). Serve as the primary... ...experience in regulatory affairs for Senior Director level. Minimum of... ...level. Experience in Oncology, Hematology, or related specialty...SeniorRegulatory
$134.62k - $201.25k
Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Quality Control for biologics to ensure all testing meets regulations... ..., managing analytical strategies, and supporting global regulatory submissions. The ideal candidate will possess a Ph.D., MS, or BS in a...SeniorRegulatory- ...a CRA/Sr CRA in the US. Oncology Experience required. Cell therapy... ...for study start-up and regulatory maintenance. Tasks may include... ...the application process; submission of proper application/documents... ...Collaborates with local Medical Science Liaisons (MSLs) as directed...SeniorRegulatoryLocal areaRemote workFlexible hoursShift work
$25.95 - $38.93 per hour
...person to join our Children's Oncology Group Research Team here at... ...and recommends solutions. Regulatory - identifies and liaises with... ...Board (IRB) preparation and submission. Study Participation -... ...incentives, paid time off, medical, dental and vision insurance...SeniorRegulatoryHourly payMonday to FridayShift work- ...Senior Regulatory Affairs Specialist Job Description This person will be joining a small, but... ...those strategies to completion through submission in the US and internationally. You will... ...years of experience in orthopedic or medical device industry. A minimum of 5 years...SeniorRegulatory
- ...Senior Director, Drug Safety & Pharmacovigilance About the Company... ...ensuring compliance with all regulatory requirements and guidance.... ...with clinical leads and medical monitors, serving as the primary... ...ensure high-quality, timely submissions to regulatory agencies and stakeholders...SeniorRegulatory
$169.22k - $253k
...optimization, process validation readiness, and regulatory engagements. The ideal candidate will... ...a PhD with extensive experience in CMC submissions and regulatory compliance. The position... ...Comprehensive company benefits include medical, dental, vision coverage, a generous 40...SeniorRegulatoryFlexible hours- ...CO is seeking a Financial Reporting and Technical Accounting Senior Manager to lead SEC filings and strengthen internal controls... ...ensure timely, accurate GAAP-based reporting and coordinate regulatory submissions. You will coach the Reporting and Technical Accounting team,...SeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry, Manufacturing... ...strategies for biologic products and work on regulatory submissions, ensuring alignment with global requirements. The ideal...SeniorRegulatoryRemote jobWorldwide
- ...demonstrate adherence to NERC requirements. Assist in audit preparation and submission of supporting data requests, compiling documentation (e.g. Reliability Standard Audit Worksheets), and supporting regulatory inspections and NERC audits under the guidance of the Team Leader....SeniorRegulatoryWork at office
- ...Senior Regulatory Affairs Specialist page is loaded## Senior Regulatory Affairs Specialistlocations... ...product lifecycle, manage regulatory submissions, advise stakeholders on regulatory... ...experience within a regulated industry (e.g., medical devices, IVDs, pharmaceuticals,...SeniorRegulatoryFor contractorsLocal area
$234k - $271k
...a related field with extensive industry experience. The responsibilities include developing advanced algorithms, managing regulatory submissions, and mentoring junior scientists. The position offers a competitive salary ranging from $234,000 to $271,000, along with a...SeniorRegulatoryRemote work$40k - $100k
...in Denver, CO. This role involves collecting documents from research sites, maintaining trial documentation, and organizing regulatory submissions. The ideal candidate should have a Bachelor's degree in Life Sciences and at least 3 years' experience in clinical research...SeniorRegulatoryContract workFlexible hours- A clinical laboratory is seeking a Regulatory Affairs specialist in Denver, Colorado, with at least 8 years of experience. The role involves preparing documents for regulatory submissions, engaging with FDA and cross-functional teams, and reviewing promotional materials...Regulatory
$230k
Nova Pneuma in Colorado is seeking a Senior Regulatory Affairs Manager to oversee regulatory strategies and submissions for product candidates. The ideal candidate will have a bachelor’s degree in a scientific discipline and over 10 years of relevant regulatory experience...Regulatory$96.25k - $137.5k
...DISH. Job Duties and Responsibilities The Senior HR Business Partner has foundational HR... ...Provide expertise in technical and regulatory aspects of employment, including hiring,... ...from your application documents before submission and throughout our application process....SeniorRegulatoryHourly payLocal areaFlexible hours$155k - $165.2k
...Charlotte, NC) Position Summary The Senior Manager, Government Programs... ..., and change management of regulatory requirements for Exchange... ...timeliness of all required submissions Support internal and external... ...national origin, disability status, medical condition, genetic...SeniorRegulatoryLocal areaFlexible hoursShift work$85k - $95k
LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations and regulatory submissions for active implantable medical devices. The role entails preparing evaluation plans, managing submissions, and collaborating across teams to ensure compliance...RegulatoryRemote jobFlexible hours$180k - $220k
...and business need. SUMMARY: The Senior Medical Science Liaison (Sr MSL), Movement Disorders... ...-initiated trials (IITs), grant submissions, and research collaborations aligned with... ...accordance with Lundbeck policies and regulatory requirements on time. Maintains...SeniorRegulatoryRemote workFlexible hours- ...Title: Senior Financial Analyst Location: Hybrid 3 days... ...including R&D, IT, Quality, and Regulatory. The analyst provides... ...operates in a global, matrixed medical device environment and requires... ...Consolidate and analyze submissions and highlight variances and risks...SeniorRegulatory3 days per week
- ...might be the right bank for you. As a Senior Compliance Specialist, you will train and... ...papers for edits and thoroughness prior to submission to management. You may develop and... ...You will need the ability to interpret regulatory rules and their impact on the business....SeniorRegulatoryWork experience placementWork at officeNight shift
$134.62k - $201.25k
The Senior Manager, Quality Control (Small Molecules) will execute... ..., product release, and regulatory compliance. This role is responsible... ...NDA, ANDA, and post‑approval submissions through preparation, review,... ...benefits: Comprehensive medical, dental, vision, prescription...SeniorRegulatoryContract workTemporary workLocal areaFlexible hours$180k - $220k
...seeking a strategic and highly collaborative Senior Product Lead to support our client, a healthcare SaaS company focused on oncology care, to lead the vision, strategy, and... ...across all touchpoints. Lead compliance, regulatory, and enhancement initiatives while...SeniorRegulatoryFull timeWork at officeRelocation
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